Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
cefaclor monohydrate, Quantity: 52.45 mg/mL (Equivalent: cefaclor, Qty 50 mg/mL)
Alphapharm Pty Ltd
Oral Liquid, powder for
Excipient Ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; erythrosine; sucrose; pregelatinised starch; Flavour
Oral
75mL
(S4) Prescription Only Medicine
KEFLOR is indicated for the treatment of the following types of infections caused by or likely to be caused susceptible organisms: Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. Upper respiratory infections, including pharyngitis, tonsillitis and otitis media. Skin and skin structure infections. Urinary tract infections, including pyelonephritis and cystitis. NOTE: 1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. KEFLOR appears to be effective as phenoxymethul penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor.
Visual Identification: A pink free-flowing dry powder. After constitution a red coloured suspension with a characteristic strawberry odour.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1997-02-19
KEFLOR _cefaclor monohydrate suspension_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Keflor. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Keflor against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT KEFLOR IS USED FOR Keflor is used to treat infections in different parts of the body caused by bacteria. Keflor can be used to treat infections of the: • ear, nose, throat and tonsils (upper respiratory tract) • chest and lungs (lower respiratory tract) • bladder and kidneys (urinary tract) • skin. Your doctor may have prescribed Keflor for another reason. Ask your doctor if you have any questions about why Keflor has been prescribed for you. Keflor is an antibiotic that belongs to a group of medicines called cephalosporins. These medicines work by killing the bacteria that are causing your infection. Keflor will not work against infections caused by viruses, such as colds or flu. Keflor is available only with a doctor's prescription. There is no evidence that Keflor is addictive. BEFORE YOU TAKE KEFLOR _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE KEFLOR IF YOU ARE ALLERGIC TO MEDICINES CONTAINING: • CEFACLOR MONOHYDRATE • ANY OTHER CEPHALOSPORIN • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing, wheezing or shortness of breath. DO NOT TAKE KEFLOR IF YOU HAVE HAD A SEVERE ALLERGIC REACTION TO PENICILLIN. DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE AGE OF 1 MONTH. Safety and effectiveness in children younger than 1 month have not been establish Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION KEFLOR _Cefaclor monohydrate powder for oral suspension _ 1 NAME OF THE MEDICINE Cefaclor monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Keflor contains cefaclor monohydrate, equivalent to 125 mg or 250 mg of cefaclor per 5 mL upon reconstitution. Excipients with known effect: Sugars as sucrose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM KEFLOR 125 mg/5 mL is a powder for oral suspension. The powder is a pink free-flowing dry powder. After reconstitution, it is a red coloured suspension with a characteristic strawberry odour. KEFLOR 250 mg/5 mL is a powder for oral suspension. The powder is a pink free-flowing dry powder. After reconstitution, it is a red coloured suspension with a characteristic strawberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Keflor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms: • Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. • Upper respiratory infections, including pharyngitis, tonsillitis and otitis media. • Skin and skin structure infections. • Urinary tract infections, including pyelonephritis and cystitis. NOTE: 1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflor appears to be as effective as phenoxymethyl penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. 4.2 DOSE AND METHOD OF ADMINISTRATION Keflor is administered orally. DIRECTIONS FOR RECONSTITUTION OF KEFLOR FOR ORAL SUSPENSION 125 MG/5 ML - Add 60 mL of water in two portions to the dry mixtur Прочетете целия документ